• Neratinib causes significant gast

•来那替尼导致显著的胃肠毒性。腹泻会影响大多数患者，严重的比例很高，并且可以预期会影响生活质量。基于从研究6201提供的数据，它是在这个时候是否腹泻可以通过预防性止泻充分管理不确定性。该试验的早期停药尽管密集的预防洛哌丁胺率很高，是值得关注的。目前还不清楚到什么程度的腹泻可能会逐渐增加对个体患者谁决定在经历严重腹泻后，留在治疗和经历3级腹泻时，有再激发后没有证据的耐受性。在稳健表现出效益的情况下，新兴的副作用轮廓不会是一个阻塞问题; 然而，

• Neratinib causes significant gastrointestinal toxicity. Diarrhoea affects most patients, is severe in a high proportion, and can be expected to affect quality of life. Based on available data from study 6201, it is uncertain at this time whether the diarrhoea can be adequately managed by prophylactic anti-diarrhoeals. The high rate of early discontinuations from this trial despite intensive loperamide prophylaxis is of concern. It is also unclear to what extent diarrhoea may improve over time for the individual patient who decides to remain on treatment after experiencing severe diarrhoea and there is no evidence for tolerability after rechallenge when experiencing Grade 3 diarrhoea. In the presence of a robustly demonstrated benefit, the emerging side effect profile would not be a blocking issue; however, in the context the deficiencies in the efficacy demonstration, the adverse effect profile of neratinib is a matter of important concern. ...

•尼拉替尼引起严重的胃肠道毒性。腹泻影响大多数患者，严重程度很高，预计会影响生活质量。根据研究6201的现有数据，目前尚不确定预防性抗腹泻药是否能充分控制腹泻。尽管进行了大量的洛佩胺预防，但该试验的早期中止率很高，值得关注。对于在经历严重腹泻后决定继续治疗的个体患者，腹泻随着时间的推移可能改善到何种程度还不清楚，而且在经历3级腹泻时，没有证据表明再次激发后的耐受性。在存在充分证明的益处的情况下，出现的副作用情况不会是一个阻碍性问题；然而，在疗效证明存在缺陷的情况下，尼拉替尼的副作用情况是一个重要的关注事项。